Back to resultsOptimisation of Functional MRI-based Neurofeedback for Alcohol Use Disorders
Primary Purpose
Alcohol Abuse
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Neurofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Abuse
Eligibility Criteria
Inclusion Criteria:
- History of alcohol use disorder or current alcohol consumption above 21 units (1 unit = 8g) of alcohol per week (male participants) or above 14 units of alcohol per week (female participants)
Exclusion Criteria:
- MRI safety exclusion criteria
Sites / Locations
- School of Medicine, Cardiff University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neurofeedback
Arm Description
Outcomes
Primary Outcome Measures
Neurofeedback success (brain activation difference during neurofeedback and baseline blocks)
This measure will be based on the analysis of participants' fMRI (functional magnetic resonance imaging) data, reflecting brain activation, during exposure to alcohol cues. Neurofeedback success will be defined as significant difference between activation levels (expressed as beta weights of a linear regression model) during the regulation periods compared to baseline. The significance will be determined by a t-test.
Secondary Outcome Measures
Drinking Urges Questionnaire as a measure of alcohol craving
Measure of alcohol craving
Alcohol Stroop task as a measure of cognitive bias
Measure of cognitive bias
Full Information
NCT ID
NCT02406456
First Posted
March 26, 2015
Last Updated
November 10, 2015
Sponsor
Cardiff University
Collaborators
European Commission
1. Study Identification
Unique Protocol Identification Number
NCT02406456
Brief Title
Optimisation of Functional MRI-based Neurofeedback for Alcohol Use Disorders
Official Title
Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence - Protocol Optimisation Phase
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiff University
Collaborators
European Commission
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Participants will undergo a single session of functional magnetic resonance imaging (fMRI)-based neurofeedback (approximately 1 hour). The investigators will assess their ability to regulate motivational networks of the brain during the exposure to alcohol cues and evaluate immediate effects on craving and cognitive bias for alcohol by administering a questionnaire and a Stroop task before and after the session.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neurofeedback
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Neurofeedback
Primary Outcome Measure Information:
Title
Neurofeedback success (brain activation difference during neurofeedback and baseline blocks)
Description
This measure will be based on the analysis of participants' fMRI (functional magnetic resonance imaging) data, reflecting brain activation, during exposure to alcohol cues. Neurofeedback success will be defined as significant difference between activation levels (expressed as beta weights of a linear regression model) during the regulation periods compared to baseline. The significance will be determined by a t-test.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Drinking Urges Questionnaire as a measure of alcohol craving
Description
Measure of alcohol craving
Time Frame
1 day
Title
Alcohol Stroop task as a measure of cognitive bias
Description
Measure of cognitive bias
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
History of alcohol use disorder or current alcohol consumption above 21 units (1 unit = 8g) of alcohol per week (male participants) or above 14 units of alcohol per week (female participants)
Exclusion Criteria:
MRI safety exclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Linden, MD
Organizational Affiliation
Cardiff University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Medicine, Cardiff University
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Optimisation of Functional MRI-based Neurofeedback for Alcohol Use Disorders
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